Early Primary Prophylaxis of Esophageal Varices

Not Applicable

Completed

• Conditions: Cirrhosis
• Interventions: Drug: Placebo; Drug: Carvedilol

• Registration Number: NCT01196507
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal varices with or without red color signs and have not bled previously will be enrolled. After baseline evaluation, the participants will be randomized to receive either Placebo or Carvedilol 12.5 mg BD. After randomization they will be followed up for one year. The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) at 1 year in each group. The secondary endpoint are survival,reduction in HVPG,change in CTP and MELD score\& adverse events.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-04
• Study First Submitted QC: 2010-09-04
• Study First Posted: 2010-09-08
• Study Start: 2010-11
• Status Verified: 2013-12
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2016-06-14
• Last Update Posted: 2016-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal varices with or without red color signs and have not bled previously.

Exclusion Criteria

• Any contra-indication to beta-blockers
• Any EVL or sclerotherapy within last 3 months
• Child Turcotte Pugh (CTP) score > 12, refractory ascites, hepatorenal syndrome
• Any past history of surgery for portal hypertension
• Significant cardio or pulmonary co-morbidity
• Any malignancy that affects survival.
• Active alcohol abuse or last intake ≤ 4 weeks to avoid possibility of ongoing alcohol hepatitis.
• Past history of surgery for portal hypertension
• Uncontrolled diabetes
• Peripheral vascular disease
• Refusal to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablets 2 to 4 BD
Carvedilol	Carvedilol	Tablet Carvedilol 12.5 mg BD or maximum tolerated dose

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) during the period of 2 year in each group.	2 Years

Secondary Outcome Measures

Name	Time	Method
Survival	2 Years
reduction in HVPG	1 Year
adverse effects of drugs	2 Years

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences (ILBS); 🇮🇳 New Delhi, Delhi, India